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This study is a randomized multi-center trial that will assess the effect of adding SIRT, using SIR-Spheres microspheres, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation.

Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm).

Suitable for either treatment regimen.

Prior chemotherapy for metastatic colorectal cancer is not allowed.

WHO performance status 0-1.

Adequate hematological, renal and hepatic function.

Age 18 years or older.

Willing and able to provide written informed consent.

Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.

Previous radiotherapy delivered to the upper abdomen.

Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.

Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.